DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of preparing a graft, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/26.
Applicant’s election without traverse of claims 1-16 in the reply filed on 02/17/26 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations "wherein the suture receiver is configured to enable… the suture to be looped around the tissue while maintaining the suture under constant tension by receiving a portion of a suture under tension” in lines 6-8. It is unclear if “the suture” and “a suture” are the same suture or different sutures. For examination purposes, the limitation will interpreted as the same suture. Claims 2-15 are rejected for the same reasons as claim 1 by virtue of dependency on claim 1.
Claim 16 recites the limitations "wherein the suture receiver is configured to enable… the suture to be looped around the tissue while maintaining the suture under constant tension by receiving a portion of a suture under tension” in lines 6-8. It is unclear if “the suture” and “a suture” are the same suture or different sutures. For examination purposes, the limitation will interpreted as the same suture.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11, 13-14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yap et al. (US 2003/0065247).
Regarding claim 1, an invention relating to graft preparation devices, Yap discloses (Fig. 1) a graft support system (10), comprising: at least one tissue receiver (40) configured to retain a tissue (5; Par. 0021); a suture receiver (12, 30, 32, 34, 36) supported remotely from at least one surface (see annotated figure below) and configured to support the at least one tissue receiver remote relative to the at least one surface such that material can be passed between the at least one surface and the tissue supported by the graft support system [i.e. an object can be passed between elements 5 and 12] (Par. 0021); and wherein the suture receiver is configured to enable a stitch to be formed in the tissue and the suture to be looped around the tissue while maintaining the suture under constant tension by receiving a portion of a suture (see annotated figure below) under tension extending from the tissue held within the at least one tissue receiver [i.e. The language, “configured to/for" merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. "Configured for/to," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of “Yap” meets the structural limitations of the claim, and the “suture receiver” is structured to “enable a stitch to be formed in the tissue and the suture to be looped around the tissue while maintaining the suture under constant tension by receiving a portion of a suture under tension extending from the tissue held within the at least one tissue receiver”], whereby the portion of the suture under tension remains under tension by force applied to the suture when the portion of the suture under tension is manipulated from a first side of the suture receiver to a second side of the suture receiver (Par. 0022-0023).
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Regarding claim 2, Yap discloses the graft support system of claim 1. Yap further discloses (Fig. 1) wherein the suture receiver comprises a suture receiver base (12) slidably receiving a suture receiver body (30, 32, 34, 36) whereby, in a first position [i.e. a more distal position along the track], a suture receiving opening is open to receive a suture under tension from the first side of the suture receiver [i.e. jaws of element 32 are open to receive suture on left side of jaws] and, in a second position [i.e. a more proximal position along the track], a suture release opening is open to release a suture under tension from a second side of the suture receiver [i.e. jaws of element 32 are open to receive suture on left side of jaws] (Par. 0021-0022).
Regarding claim 3, Yap discloses the graft support system of claim 2. Yap further discloses (Fig. 1) wherein the suture receiver body comprises a base support member (30) and first and second arms [i.e. jaws] separated to form a suture receiving chamber [i.e. space between jaws when opening] (Par. 0027).
Regarding claim 4, Yap discloses the graft support system of claim 3. Yap discloses further comprising a first retainer on a distal end of the first arm and a second retainer on a distal end of the second arm [i.e. teeth on jaws of element 32] (Fig. 1).
Regarding claim 5, Yap discloses the graft support system of claim 2. Yap discloses further wherein the suture receiver base slidably retains the suture receiver body such that the movement of the suture receiver body is limited to movement along a single axis [i.e. the longitudinal axis of element 14] (Par. 0022).
Regarding claim 6, Yap discloses the graft support system of claim 2. Yap discloses (Fig. 1) further comprising a suture receiver body restraint [i.e. locking mechanism] (36) configured to limit movement of the suture receiver body between the first and second positions, wherein the suture receiver body restraint comprises at least one member extending from the suture receiver body to limit movement of the suture receiver body between the first and second positions along an axis [i.e. the longitudinal axis of element 14] while maintaining support of a tissue receiver support base by the suture receiver body (Par. 0014 & 0021).
Regarding claim 7, Yap discloses the graft support system of claim 1. Yap further discloses wherein the at least one tissue receiver comprises at least one post configured to receive the tissue (Par. 0027).
Regarding claim 8, Yap discloses the graft support system of claim 1. Yap further discloses wherein the at least one tissue receiver comprises at least one tissue clamp [i.e. jaws] (Par. 0021).
Regarding claim 9, Yap discloses the graft support system of claim 8. Yap further discloses (Fig. 1) wherein the at least one tissue clamp extends from a tissue receiver support base (20), which is in turn supported by the suture receiver [i.e. supported by element 12], and wherein the at least one tissue clamp is configured to grasp the tissue (Par. 0027).
Regarding claim 10, Yap discloses the graft support system of claim 9. Yap further discloses wherein the at least one tissue clamp is formed from first and second clamp arms [i.e. jaws], whereby the second clamp arm is pivotably coupled to the first clamp arm at the tissue receiver support base (Par. 0021).
Regarding claim 11, Yap discloses the graft support system of claim 10. Yap discloses (Figs. 1-2) further comprising a clamp arm retainer (24) configured to releasably secure the second clamp arm in a fixed position relative to the first clamp arm (Par. 0021).
Regarding claim 13, Yap discloses the graft support system of claim 1. Yap discloses (Fig. 1) further comprising a suture receiver support (16) configured to support the suture receiver remote relative to the at least one surface (Par. 0022).
Regarding claim 14, Yap discloses the graft support system of claim 13. Yap discloses further comprising at least one releasable connection system configured to enable the suture receiver support to be releasably attachable to the at least one surface [i.e. the slot within element 12 which element 16 is slid into] (Par. 0022).
Regarding claim 16, an invention relating to graft preparation devices, Yap discloses (Fig. 1) a graft support system (10), comprising: at least one tissue receiver (40) configured to retain a tissue (5; Par. 0021); a suture receiver (12, 30, 32, 34, 36) supported remotely from at least one surface (see annotated figure below) and configured to support the at least one tissue receiver remote relative to the at least one surface such that material can be passed between the at least one surface and the tissue supported by the graft support system [i.e. an object can be passed between elements 5 and 12] (Par. 0021); wherein the suture receiver is configured to enable a stitch to be formed in the tissue and the suture to be looped around the tissue while maintaining the suture under constant tension by receiving a portion of a suture (see annotated figure below) under tension extending from the tissue held within the at least one tissue receiver [i.e. The language, “configured to/for" merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. "Configured for/to," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of “Yap” meets the structural limitations of the claim, and the “suture receiver” is structured to “enable a stitch to be formed in the tissue and the suture to be looped around the tissue while maintaining the suture under constant tension by receiving a portion of a suture under tension extending from the tissue held within the at least one tissue receiver”], whereby the portion of the suture under tension remains under tension by force applied to the suture when the portion of the suture under tension is manipulated from a first side of the suture receiver to a second side of the suture receiver (Par. 0022-0023); wherein the suture receiver comprises a suture receiver base (12) slidably receiving a suture receiver body (30, 32, 34, 36) whereby, in a first position [i.e. a more distal position along the track], a suture receiving opening is open to receive a suture under tension from the first side of the suture receiver [i.e. jaws of element 32 are open to receive suture on left side of jaws] and, in a second position [i.e. a more proximal position along the track], a suture release opening is open to release a suture under tension from a second side of the suture receiver [i.e. jaws of element 32 are open to receive suture on left side of jaws] (Par. 0021-0022); and wherein the at least one tissue receiver comprises at least one tissue clamp [i.e. jaws] (Par. 0021).
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yap et al. (US 2003/0065247) as applied to claim 10 above, and further in view of Marks et al. (US 2015/0272721).
Regarding claim 12, Yap discloses the graft support system of claim 10. However, Yap fails to disclose further comprising a suture card receiver slot in the second clamp arm enabling the second clamp arm to receive an implant card containing a suture which enables sutures to be stored in close proximity to the site of use in the tissue.
In the same field of endeavor, which is graft preparation devices, Marks teaches (Figs. 17A-B) a suture card receiver slot (2022’) in a second clamp arm (2006’) enabling the second clamp arm to receive an implant card (900) containing a suture (11 & 14) which enables sutures to be stored in close proximity to the site of use in the tissue (Par. 0056 & 0156).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yap to have a suture card receiver slot in the second clamp arm enabling the second clamp arm to receive an implant card containing a suture which enables sutures to be stored in close proximity to the site of use in the tissue. Doing so would provide a management device to help prepare for the surgical procedure (Par. 0054), as taught by Marks.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Yap et al. (US 2003/0065247) as applied to claim 1 above, and further in view of Viitala et al. (US 2009/0112053).
Regarding claim 15, Yap discloses the graft support system of claim 1. Yap fails to disclose further comprising a rotatable support structure configured to enable the at least one tissue receiver to be rotated along an axis generally aligned with the tissue supported by the graft support system.
In the same field of endeavor, which is graft preparation devices, Viitala teaches (Fig. 1) a rotatable support structure (31) configured to enable at least one tissue receiver (32 & 33) to be rotated along an axis generally aligned with the tissue supported by the graft support system (Par. 0025).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yap to have a rotatable support structure configured to enable the at least one tissue receiver to be rotated along an axis generally aligned with the tissue supported by the graft support system. Doing so would allow tissue to be easily reoriented (Par. 0025), as taught by Viitala.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 June 26, 2026
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